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Data / Medical devices / United States / Premium Plus Dental Supplies Inc

Premium Plus Dental Supplies Inc: FDA-registered device maker in Brooklyn, NY, United States, 31 510(k) clearances and 2 PMA approvals

Premium Plus Dental Supplies Inc is registered with the FDA (registration 3004425647) in Brooklyn, NY, United States. It lists 71 device types. The FDA files 31 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 9, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3004425647
Address
155 Liberty Ave, Brooklyn, NY, United States, 11212
Owner or operator
PREMIUM PLUS DENTAL (9070342)
Roles
Complaint file establishment
First device listed
September 20, 2005
Registered through
2026
Brand names listed
AEI Burnishers, AGENT, ABSORBABLE HEMOSTATIC ,NON-COLLAGEN BASED, AGENT, TOOTH BONDING ,RESIN, Agent, Tooth Bonding , Resin, CEMENT , DENTAL, CLAMP. RUBBER DAM, CURETTE,SURGICAL DENTAL, CX-1 Explorer, DG-16 Explorer and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Complaint file establishmentaccessdata.fda.gov
Accessories, Retractor, DentalEIF1Complaint file establishmentaccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Complaint file establishmentaccessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen BasedLMF3Complaint file establishmentaccessdata.fda.gov
Agent, Absorbable Hemostatic, Non-Collagen BasedLMG3Complaint file establishmentaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishmentaccessdata.fda.gov
Applicator, ResinKXR1Complaint file establishmentaccessdata.fda.gov
ArticulatorsEJP1Complaint file establishmentaccessdata.fda.gov
Bracket, Metal, OrthodonticEJF1Complaint file establishmentaccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Complaint file establishmentaccessdata.fda.gov
Bur, DentalEJL1Complaint file establishmentaccessdata.fda.gov
Burnisher, OperativeEKJ1Complaint file establishmentaccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Complaint file establishmentaccessdata.fda.gov
Cement, DentalEMA2Complaint file establishmentaccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Complaint file establishmentaccessdata.fda.gov
Clamp, Rubber DamEEF1Complaint file establishmentaccessdata.fda.gov
Clamp, Wire, OrthodonticECN1Complaint file establishmentaccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Complaint file establishmentaccessdata.fda.gov
Container, SharpsMMK2Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishmentaccessdata.fda.gov
Cotton, RollEFN1Complaint file establishmentaccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Complaint file establishmentaccessdata.fda.gov
Crown, PreformedELZ1Complaint file establishmentaccessdata.fda.gov
Cup, ProphylaxisEHK1Complaint file establishmentaccessdata.fda.gov
Curette, PeriodonticEMS1Complaint file establishmentaccessdata.fda.gov
Curette, Surgical, DentalEMK1Complaint file establishmentaccessdata.fda.gov
Dental Barriers And SleevesPEM2Complaint file establishmentaccessdata.fda.gov
Denture, Plastic, TeethELM2Complaint file establishmentaccessdata.fda.gov
Disk, AbrasiveEHJ1Complaint file establishmentaccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Complaint file establishmentaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Complaint file establishmentaccessdata.fda.gov
Explorer, OperativeEKB1Complaint file establishmentaccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Complaint file establishmentaccessdata.fda.gov
Forceps, Dressing, DentalEFL1Complaint file establishmentaccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Complaint file establishmentaccessdata.fda.gov
Frame, Rubber DamEJE1Complaint file establishmentaccessdata.fda.gov
Handle, Instrument, DentalEJB1Complaint file establishmentaccessdata.fda.gov
Holder, Film, X-RayEGZ1Complaint file establishmentaccessdata.fda.gov
Instrument, Diamond, DentalDZP1Complaint file establishmentaccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Complaint file establishmentaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishmentaccessdata.fda.gov
Instruments, Dental HandDZN1Complaint file establishmentaccessdata.fda.gov
Mask, SurgicalFXX2Complaint file establishmentaccessdata.fda.gov
Material, ImpressionELW2Complaint file establishmentaccessdata.fda.gov
Material, Impression Tray, ResinEBH1Complaint file establishmentaccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Complaint file establishmentaccessdata.fda.gov
Mirror, MouthEAX1Complaint file establishmentaccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Complaint file establishmentaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Complaint file establishmentaccessdata.fda.gov
Paper, ArticulationEFH1Complaint file establishmentaccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Complaint file establishmentaccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Complaint file establishmentaccessdata.fda.gov
Point, AbrasiveEHL1Complaint file establishmentaccessdata.fda.gov
Probe, PeriodonticEIX1Complaint file establishmentaccessdata.fda.gov
Resin, Root Canal FillingKIF2Complaint file establishmentaccessdata.fda.gov
Retractor, All TypesEIG1Complaint file establishmentaccessdata.fda.gov
Scaler, PeriodonticEMN1Complaint file establishmentaccessdata.fda.gov
Scraper, TongueLCN1Complaint file establishmentaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishmentaccessdata.fda.gov
Staple, Removable (Skin)GDT1Complaint file establishmentaccessdata.fda.gov
Strip, Polishing AgentEHM1Complaint file establishmentaccessdata.fda.gov
Syringe, AntistickMEG2Complaint file establishmentaccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishmentaccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Complaint file establishmentaccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Complaint file establishmentaccessdata.fda.gov
Tester, PulpEAT2Complaint file establishmentaccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Complaint file establishmentaccessdata.fda.gov
Tray, Impression, PreformedEHY1Complaint file establishmentaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Complaint file establishmentaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Complaint file establishmentaccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 9, 2023K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single UseFMFSubstantially EquivalentJiangsu Zhiyu Medical Instrument Co, Ltd.accessdata.fda.gov
October 28, 2022K222581Stela Automix SystemEBFSubstantially EquivalentSdi Limitedaccessdata.fda.gov
August 30, 2022K214118Riva Cem AutomixEMASubstantially EquivalentSdi Limitedaccessdata.fda.gov
June 25, 2020K200175DIA-ROOT BIO SealerKIFSubstantially EquivalentDiaDent Group Internationalaccessdata.fda.gov
December 2, 2019K191656ZipbondKLESubstantially EquivalentSdi Limitedaccessdata.fda.gov
January 2, 2019K1834763M Filtek Universal RestorativeEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
August 22, 2016K153514Premium Plus C01/C02 LED Curing LightEBZSubstantially EquivalentPremium Plus International Limitedaccessdata.fda.gov
July 27, 2016K160596BEAUTIFIL II LSEBFSubstantially EquivalentShofu Dental Corporationaccessdata.fda.gov
March 3, 2016K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEMSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
March 4, 2015K142990Insta-Gard Surgical and Procedure Face MaskFXXSubstantially EquivalentCardinal Health200, LLCaccessdata.fda.gov
May 19, 2011K110302ADHESIVE EXL-759KLESubstantially Equivalent3M Espe AGaccessdata.fda.gov
December 8, 2010K102984AURAEBFSubstantially EquivalentSdi Limitedaccessdata.fda.gov
August 23, 2010K101603BEAUTIFIL FLOW PLUSEBFSubstantially EquivalentShofu Dental Corp.accessdata.fda.gov
April 8, 2010K094007UNICEMEMASubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
January 16, 2008K073206NEEDLE-TRAP/NEEDLE SAFETY LABELMEGSubstantially EquivalentSchreiner Medipharmaccessdata.fda.gov
August 15, 2007K071742BEAUTIFIL IIEBFSubstantially EquivalentShofu Dental Corp.accessdata.fda.gov
July 27, 2005K051867GRANDIOEBFSubstantially EquivalentVoco GmbHaccessdata.fda.gov
April 7, 2004K040769STRUCTUR 2 SCEBGSubstantially EquivalentVoco GmbHaccessdata.fda.gov
August 11, 2003K032001POLY Q (GARANT L, PENTA M, PENTA H)ELWSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
July 19, 2002K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMISubstantially EquivalentBdaccessdata.fda.gov
October 22, 2001K012528ICEEBFSubstantially EquivalentSouthern Dental Industries, Ltd.accessdata.fda.gov
December 8, 1997K973091WAVEEBFSubstantially EquivalentSouthern Dental Industries, Inc.accessdata.fda.gov
March 1, 1995K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZESFMFSubstantially EquivalentSherwood Medical Co.accessdata.fda.gov
August 29, 1994K941991IN-ROOM AND SHARPSTARMMKSubstantially EquivalentSage Products, Inc.accessdata.fda.gov
March 20, 1992K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
March 2, 1992K914476VITAPAN ACRYLIC DENTURE TEETHELMSubstantially EquivalentVidentaccessdata.fda.gov
October 4, 1991K913537MEMOSIL C.D.ELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
August 11, 1988K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov
March 1, 1988K875133CAVIT-WEBGSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
August 31, 1978K781151REPROSILELWSubstantially EquivalentDentsply Intl.accessdata.fda.gov
February 28, 1978K780301CAULK TYLOKEMASubstantially EquivalentL.D. Caulk Co.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 30, 1999P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USPLMF79September 18, 2026accessdata.fda.gov
October 14, 1960N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG120July 28, 2026accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.